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New audio processor aims to help cochlear implant users hear better in noise

NCT ID NCT04918654

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the RONDO 3, a new single-unit audio processor for people with cochlear implants. It includes features like beamforming and noise reduction to help users hear speech in noisy places. Twenty experienced users participated to see if these features improve hearing and satisfaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RONDO 3 single-unit audio processor with automatic sound management features
What this could lead to
If successful, this could lead to better hearing in noisy environments for cochlear implant users, improving daily communication and quality of life.
What could go wrong
This is a small, completed study with only 20 participants, so results may not apply to all users. The improvements are incremental, not a breakthrough.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

20 people

The number who actually took part.

Started

Jun 2021

Finished

Dec 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Post-lingually deafened adult cochlear implant users with a MED-EL device.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A minimum of 18 years old * Experienced user of a RONDO 3 (≥ 3 months) for the ear to be tested * Post-lingual onset of severe to profound sensory-neural hearing loss on the ear to be tested * A minimum of 40% speech recognition in the Freiburg Monosyllables Test in quiet at 65 dB SPL for the ear to be tested (at the last time tested in clinical routine) * Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure. Exclusion criteria * Lack of compliance with any inclusion criteria * CI user with contralateral hearing equal to or better than 30 dB (pure-tone average over the following frequencies: 250, 500, 1000, and 2000 Hz) * Implanted with C40X, or C40C on the ear to be tested * Implanted with an Auditory Brainstem Implant (ABI) or split electrode array * Known allergic reactions to components of the investigational medical device (RONDO 3) or the SONNET 2 * Anything that, in the opinion of the Investigator, would (a) place the subject at increased risk, (b) preclude the subject's full compliance with or completion of the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • MHH - Medizinische Hochschule Hannover

    Hanover, 30625, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.